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Medical Device Regulatory Affairs: CE (Canada) and FDA
Expert has 25 years' experience in FDA, TGA, CE, and Health Canada product approvals for medical devices and combination devices. He has experience writing CER, CE applications, FDA applications, TGA and Health Canada applications. He has performed PMS, PMCF, recall,…
Dental Medical Device Industry
Expert is a marketing and advertising professional with a decade of experience in the cosmetics and dental industries. She is currently a marketing consultant at Bio-Concept Dental Implants (as of 1/2016). Prior, Ms. Expert was a Product Manager for the…
Upstream Oil and Gas Industry
Expert has more than 30 years in oilfield service industry. After earning his Bachelor's degree in Petroleum Engineering from University of Oklahoma in 1983, he spent a decade with Halliburton in North America and throughout the MENA region. Later he…
Pharmaceutical Manufacturing, Combination Products, Medical Devices, and Good Clinical Practices
Expert is a retired Public Health Service (PHS) Officer with 16 years of FDA experience in Pharmaceuticals, Medical Devices, Biologics, and Bioresearch Monitoring. She has held the positions of Investigator, Pre-Approval Manager, Supervisory Investigator, and Foreign Inspection Cadre Member. She…
Plumbing Engineering and Design
Expert has served as Senior Plumbing Designer in various capacities for several years. He has worked on such projects as corporate commercial facilities, multi-family high-rise and mid-rise facilities, assisted living facilities, federal facilities, healthcare facilities, fast food restaurants, dental clinics,…
Healthcare Vendor Management
He is a Subject Matter Expert in all aspects of pharmacy benefit management vendor oversight for the health plans. This includes all operational, contractual, financial, network adequacy, utilization and quality management aspects of these relationships to assure compliance with all…
Materials Technology, Powder Metallurgy, Advanced Ceramics, Process & Product Development, R&D, Lean
25+ years of experience in successfully managing and spearheading R&D and Operations projects to completion. Developed new products and processes, led cross-functional teams, project management and implementation, mentored subordinates and peers, provided team building and leadership, problem solving skills, and…
Electric Motor Design, Position Sensors, Resolvers, Servomotors, Gyromotors, and Brushless DC Motors
Expert is a seasoned electromechanical engineer and designer with over 3 decades of professional experience in the field of electromechanics. He has 22 years' experience in the design and manufacturing of high-efficiency small electric motors, angle position and linear sensors…
Military Ammunition Design, Production, Use, Misuse, and Field Forensics of Incidents/Malfunctions
Expert, by virtue of his 38 years of specialized employment at the U.S. Army Research, Development and Engineering Center, along with an additional 5 years as Senior Technical Expert for the Project manager's Office has achieved a base of technical…
Cosmetic Dermatology products & services, including Neuromodulators/Dermal Fillers/Lasers/Peels
Expert began injecting Botox Cosmetic® when it was FDA-approved for strabismus, but not yet for wrinkles. Then a resident at the University of Miami Miller School of Medicine's Department of Dermatology & Cutaneous Surgery, she was among the first physicians…